NCT01417078

Brief Summary

The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray following a single dose in epileptic patients experiencing a seizure episode.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

March 29, 2017

Completed
Last Updated

March 29, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

August 12, 2011

Results QC Date

December 16, 2016

Last Update Submit

February 28, 2017

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax),

    Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Cmax. The mean Cmax value was adjusted to a 20 mg dose.

    Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours

  • Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax)

    Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Tmax. The mean Tmax value was adjusted to a 20 mg dose.

    Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours

  • Pharmacokinetic (PK) Parameter: Area Under The Concentration Curve From Time 0 to 12 Hours (AUC(0-12)) and AUC Time to Last Measurable Plasma Concentration

    Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter AUC(0-12) and AUC(last). The mean estimate of AUC(0-12) was adjusted to a 20 mg dose. AUC(last) was used for the calculation of AUC for nordiazepam. AUC(0-12) values could not be estimated for nordiazepam given that nordiazepam concentrations were rising between 6 and 12 hours.

    Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours

Secondary Outcomes (1)

  • Number of Patients With Treatment Emergent Adverse Events (TEAEs)

    Pre-dose to 48 hours post-dose

Study Arms (1)

Diazepam Nasal Spray

EXPERIMENTAL
Drug: Diazepam

Interventions

DiazepamDRUG

single-dose; dosage in mg, based on patient body weight

Diazepam Nasal Spray

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide signed informed consent for study participation.
  • General good health with no clinically significant unstable abnormalities.
  • Diagnosis of epilepsy.

You may not qualify if:

  • Individuals receiving warfarin (Coumadin®) or dabigatran (Pradaxa®).
  • Use of any investigational drug within 30 days.
  • Blood or plasma donation within 30 days.
  • Not willing or unable to tolerate blood draws.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Barrow Neurology Clinics at St Joseph's Hospital

Phoenix, Arizona, 85013, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Diazepam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Executive Medical Director - Clinical Development & Medical Affairs
Organization
Acorda Therapeutics, Inc.
dsquillacote@acorda.com
914-347-4300

Study Officials

  • David P Ward, MD

    Neuronex, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 16, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

March 29, 2017

Results First Posted

March 29, 2017

Record last verified: 2017-02

Locations

US(4)